Recall Z-0753-2017— Ecolab Inc

Name: FDA recall Z-0753-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-30

Class III · Terminated

Class III FDA medical device recall by Ecolab Inc, initiated 2016-11-30, terminated 2019-08-21. It names one FDA 510(k) clearance: K882724. Product: Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.. Reason: The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels..

Recalling firm: Ecolab Inc
Classification: Class III
Status: Terminated
Initiated: 2016-11-30
Terminated: 2019-08-21
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K882724 — MICROTEK PROBE DRAPEMicrobio-Medics, Inc.·cleared 1988-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

Reason for recall

The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.

Data sourced from openFDA. This site is unofficial and independent of the FDA.